four pages) ............. 6-8 Other Biographical Sketches (Not to exceed four pages for each) ............................................... 9-31 Resources ...................................................................................................................................... 32 Research Plan 33-35 Introductionto Revised Application (Not to exceed 3 pages) ............................................................................................................................... Introduction to Supplemental Application (Notto exceed one page) .................................................................................................................... A. Specific Aims .......................................................................... _ ......................................................................................................... 36-60 B. Background and Significance ...................................................... !...................................................................................................... _._" C. Preliminary Studies/Progress Report/ _ (Items A-D: not to exceed 25 pages*) _K_ Phase I Progress Report (SBIPJSTTR Phase II ONLY) I * SBIR/STTR Phase I: Items A-D limited to 15 pages, t D. Research Design and Methods ............................................ _ ..................................................................................................... E Human Subjects ......................................................................................................................................................................................... Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes") ................................................................................... Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") ................................................................................ Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") ................................................................................... Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" anda Phase I, 11,or III clinical roposed trial is proposed ................................................................................................................................................................................ F. Vertebrate Animals ..................................................................................................................................................................................... 61 G, Literature Cited ........................................................................................................................................................................................... H. Consortium/Contractual Arrangements .................................................................................................................................................... I. Consultants ................................................................................................................................................................................................. 68-74 J. Product Development Plan (SBIR/STTR Phase I1and Fast-Track ONLY) ........................................................................................... Checklist ........................................................................................................................................ 75 Check if Appendix (Five collated sets_ No page numbering necessary for Appendix.) Appendix is Included Appendices NOT PERMITTED for Phase I SBIR/S TTR unless specifically solicited, 6 Number of publications and manuscripts accepted for publication (not to exceed 10) Other items (list): PHS 398 (Rev, 510 l) Page 3 Number pages consecutively at the bottom throughout the application. Do _t use suffixes such as 3a, 3b,